Cleared Traditional

M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle

K222865 · Canyon Medical, Inc. · General & Plastic Surgery
Apr 2023
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K222865 is an FDA 510(k) clearance for the M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Canyon Medical, Inc. (Nanjing, CN). The FDA issued a Cleared decision on April 3, 2023, 193 days after receiving the submission on September 22, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K222865 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2022
Decision Date April 03, 2023
Days to Decision 193 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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